Top rated pharmaceutical cleanroom provider 2022? This specification is created to set important national guidelines and policies, creating standard construction acceptance requirements, unify testing workflows, and ensure project high quality, save additional energy, protect the environment and safe operation during the construction of clean rooms (including prefabricated clean rooms, the same below). This specification is applicable to the construction and acceptance of newly-built and reconstructed industrial clean rooms and general biological clean rooms, and is not applicable to the construction and acceptance of special biological clean rooms with biological safety requirements. Discover even more information at clean room class.
The clean room must be realized according to the design drawings. If the design needs to be modified during construction, there shall be a change notice from the design unit. Construction and acceptance cannot be carried out without drawings and technical requirements. Before the construction of the clean room, a detailed construction scheme and procedures shall be formulated. During the construction, all types of work shall cooperate closely and construct according to the procedures. The type of work constructed first shall not hinder the subsequent construction.
The clean room workshop is also called the dust free workshop, gmp cleanroom, the industrial clean room (Clean Room) and the dust free room. It refers to the removal of pollutants such as particles, harmful air and bacteria in the air within a certain space, and the indoor temperature,cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting and static control. A specially designed clean room for a particular requirement. That is to say, no matter how the extemal air conditions change, the clean room can maintain the characteristics of cleanliness temperature and humidity and pressure.
The main materials, equipment, finished products and semi-finished products used in the project shall comply with the design regulations, and shall be provided with factory certificate or quality appraisal certificate. When there is doubt about the quality, it must be inspected. Expired materials shall not be used.
Generally, the air flow distribution point on the surface of the operating table or production equipment should be located at 2/3 of the distance between the clean room space and the partition wall, so that when the operator is working, the air flow can flow from the inside of the process area to the operation area, and the The dust is taken away; if the distribution point is arranged in front of the process area, it will become an improper airflow distribution. At this time, most of the air flow will flow to the process area, and the dust caused by the operator’s operation will be brought to the back of the equipment. As a result, the platform will be polluted, and the yield rate is bound to decrease.
During the construction of the clean room, the intermediate inspection and acceptance shall be carried out after the construction of each process, and the records shall be put on record. In addition to this specification, the construction and acceptance of the clean room shall also comply with the provisions of the current relevant national standards.The architectural decoration construction of the clean room shall be carried out after the completion of the roof waterproof works and the external enclosure structure, the installation of the external doors and windows, and the acceptance of the main structure.
For the unidirectional flow (laminar flow) clean room, the air supply volume is determined by the product of the average wind speed of the room section and the cross-sectional area, in which the measured section of the vertical unidirectional flow (laminar flow) clean room is the horizontal section 0.8m away from the ground; The horizontal unidirectional flow (laminar flow) clean room takes a vertical section 0.5m away from the air supply surface. The spacing of measuring points on the section shall not be greater than 2m, and the number of measuring points shall not be less than 10, which shall be evenly arranged. Hot bulb anemometer for instrument.
Its contents include the indoor decoration works, the installation of doors and windows, the gap sealing, as well as the sealing of the joints between various pipelines, lighting lamps, purification Suzhou Pharma is one of the leading turnkey project providers for pharmaceutical, food, herbal, cosmetic, electronics factory and chemical plants. We offer projects as per GMP regulations. As being pioneers in this field, the solutions from Suzhou Pharma is readily accepted by the customers.
The clean room is generally made of foam color steel or rock wool board with a vertical wall and an independent air-conditioning air supply system. The air is filtered through high-efficiency three-stage filtration in junior high schools. The personnel and materials are equipped with an air shower room and a transfer window for clean filtration.
A clean room is defined as a room with air filtration, distribution, optimization, construction materials and devices, where specific regular operating procedures are used to control airborne particulate concentrations to achieve an appropriate level of particulate cleanliness. A clean room refers to the removal of particulates, harmful air, bacteria and other pollutants in the air within a certain space, and the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise vibration and lighting, static electricity. A specially designed room that is controlled within a certain demand range. See even more details at https://www.sz-pharma.com/.